# K024010: Dover Silver Hydrogel Coated Silicone Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: The Kendall Company Div. of Tyco Healthcare Group
- Decided: Jun 11, 2003 after 189 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Kendall DOVER Silicone Foley Catheter: named in the summary without a submission number

## Most influential descendants
- K042709: Dover Silver Temperature Sensing Foley Catheter (2005), 0 descendants of its own

## Recalls of this device
- Dec 4, 2023 · Class I · Z-1050-2024: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.

## Indications for use
The proposed device is intended for use in the drainage and/or collection and/or measurement of urine. Generally drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.

Source page: https://510kreport.com/device/K024010
Methodology: https://510kreport.com/methodology